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A Cluster of Fever and Hypotension on a Surgical Intensive Care Unit Related to the Contamination of Plasma Expanders by Cell Wall Products of Bacillus stearothermophilus

Published online by Cambridge University Press:  02 January 2015

Antoni Trilla ,
Carles Codina ,
Montserrat Salles ,
Josep M. Gatell ,
Magda Zaragoza ,
Francesc Marco ,
Miquel Navasa ,
Jaume Mulet ,
Josep Ribas  and
Maria T. Jimenez de Anta
...Show all authors
Antoni Trilla*
Affiliation:
Infection Control Program, Infectious Diseases Unit, Microbiology Laboratory, Hefiatology Unit, Cardiac Surgery Unit, Department of Pharmacy, and Quality Assurance Committee, Hospital Clinic, University of Barcelona, Spain
Carles Codina
Affiliation:
Infection Control Program, Infectious Diseases Unit, Microbiology Laboratory, Hefiatology Unit, Cardiac Surgery Unit, Department of Pharmacy, and Quality Assurance Committee, Hospital Clinic, University of Barcelona, Spain
Montserrat Salles
Affiliation:
Infection Control Program, Infectious Diseases Unit, Microbiology Laboratory, Hefiatology Unit, Cardiac Surgery Unit, Department of Pharmacy, and Quality Assurance Committee, Hospital Clinic, University of Barcelona, Spain
Josep M. Gatell
Affiliation:
Infection Control Program, Infectious Diseases Unit, Microbiology Laboratory, Hefiatology Unit, Cardiac Surgery Unit, Department of Pharmacy, and Quality Assurance Committee, Hospital Clinic, University of Barcelona, Spain
Magda Zaragoza
Affiliation:
Infection Control Program, Infectious Diseases Unit, Microbiology Laboratory, Hefiatology Unit, Cardiac Surgery Unit, Department of Pharmacy, and Quality Assurance Committee, Hospital Clinic, University of Barcelona, Spain
Francesc Marco
Affiliation:
Infection Control Program, Infectious Diseases Unit, Microbiology Laboratory, Hefiatology Unit, Cardiac Surgery Unit, Department of Pharmacy, and Quality Assurance Committee, Hospital Clinic, University of Barcelona, Spain
Miquel Navasa
Affiliation:
Infection Control Program, Infectious Diseases Unit, Microbiology Laboratory, Hefiatology Unit, Cardiac Surgery Unit, Department of Pharmacy, and Quality Assurance Committee, Hospital Clinic, University of Barcelona, Spain
Jaume Mulet
Affiliation:
Infection Control Program, Infectious Diseases Unit, Microbiology Laboratory, Hefiatology Unit, Cardiac Surgery Unit, Department of Pharmacy, and Quality Assurance Committee, Hospital Clinic, University of Barcelona, Spain
Josep Ribas
Affiliation:
Infection Control Program, Infectious Diseases Unit, Microbiology Laboratory, Hefiatology Unit, Cardiac Surgery Unit, Department of Pharmacy, and Quality Assurance Committee, Hospital Clinic, University of Barcelona, Spain
Maria T. Jimenez de Anta
Affiliation:
Infection Control Program, Infectious Diseases Unit, Microbiology Laboratory, Hefiatology Unit, Cardiac Surgery Unit, Department of Pharmacy, and Quality Assurance Committee, Hospital Clinic, University of Barcelona, Spain
Miguel A. Asenjo
Affiliation:
Infection Control Program, Infectious Diseases Unit, Microbiology Laboratory, Hefiatology Unit, Cardiac Surgery Unit, Department of Pharmacy, and Quality Assurance Committee, Hospital Clinic, University of Barcelona, Spain
*
Infection Control Program, Hospital Clinic, Villarroel 170, 08036-Barcelona, Spain
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Abstract

Objective:

To evaluate an outbreak of fever and hypotension after cardiac surgical procedures and the role of polygeline, a plasma expander.

Design:

Unmatched case-control study.

Setting:

A six-bed cardiac surgery intensive care unit (SICU) of the Hospital Clinic of Barcelona (Spain), a 940-bed public teaching hospital.

Patients:

Eight cases and 25 control patients admitted to the SICU over a 4-week epidemic period.

Main Outcome Measures:

Development of hypotension (systolic blood pressure ≤ 90 mm Hg or a drop of 40 mm Hg from baseline systolic blood pressure) and fever (axillary temperature >38.5°C) within 24 hours of a cardiac surgical procedure.

Results:

The single risk factor significantly different between cases and controls was the total volume of polygeline used throughout the surgical procedure for extracorporeal circulation: a median of 1,250 mL (mean, 1,312.5 ± 842.5 mL) in cases versus 500 mL (mean, 566.0 ± 159.9 mL) in controls (P = .0029). By multiple logistic regression analysis, polygeline use was the single risk factor significantly related to the outcome (odds ratio, 8.75; CI95, 1.36 to 56.2; P= .01). Neither blood cultures from patients nor cultures of the polygeline used yielded growth of any microorganism. Stopping use of the implicated polygeline lot controlled the outbreak.

Conclusions:

Use of polygeline was associated with an outbreak of fever and hypotension in a SICU. Information from the manufacturer indicated the likelihood of contamination of the product with Bacillus stearothermophilus components. The manufacturer has since changed the production and control processes, and no further adverse events have been seen.

Type
Original Articles
Information
Infection Control & Hospital Epidemiology , Volume 16 , Issue 6 , June 1995 , pp. 335 - 339
Copyright
Copyright © The Society for Healthcare Epidemiology of America 1995

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